FDA, Health Canada give sneak peek into future AI regs

MedTech Dive October 16, 2024
Elise Reuter

Canada’s device agency plans to issue guidance on machine learning, and the FDA plans to release a draft guidance next year on lifecycle management and premarket submissions for AI devices.

TORONTO — Medical device regulators from the U.S. and Canada addressed one of the industry’s buzziest topics Tuesday at Advamed’s The MedTech Conference: artificial intelligence.

The Food and Drug Administration has authorized nearly 1,000 AI-enabled medical devices, and Health Canada has authorized hundreds. But there are still several unanswered questions about the technology, including how to monitor the performance of algorithms that can adapt over time and how to regulate generative AI tools.

FDA and Health Canada regulators shared their thoughts about these challenges and provided a glimpse at...

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